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Clinical trial within dialysis care effective but it was inconclusive whether longer sessions benefit patients
Although researchers were unable to determine whether patients might benefit from longer hemodialysis sessions, incorporating a clinical trial into routine dialysis care proved effective for acquiring data in a non-research setting, according to a published study.
“There is a pressing need for data from randomized trials to guide clinical practice in dialysis,” Laura M. Dember, MD, of the renal, electrolyte and hypertension division at the University of Pennsylvania Perelman School of Medicine, said in a press release. “Pragmatic trials embedded in clinical care delivery have tremendous potential for efficiently producing evidence that is highly generalizable to the non-research setting; however, experience with this approach is limited.”
To develop approaches for embedding trials into routine delivery of maintenance hemodialysis — and to explore whether longer sessions improve patient outcomes — researchers performed a cluster-randomized pragmatic trial demonstration project entitled the Time to Reduce Mortality in ESRD (Time) trial.
For the trial, researchers randomized 266 dialysis facilities of 7,035 patients who had started dialysis within the previous 2 years to either intervention or usual care. The intervention consisted of a default hemodialysis duration of 4.25 hours or more, while usual care consisted of an average session duration of approximately 3.5 hours.
Researchers utilized multiple strategies, including information and additional education about the intervention through teleconferences before the trial, to engage facility personnel because no research staff was on-site (the intervention was entirely implemented by clinicians). Researchers relied solely on the clinically acquired data.
The primary outcome of the trial was death. Secondary outcomes included hospitalizations, pre-dialysis blood pressure, post-dialysis hypotension, interdialytic weight gain, fluid removal rate, missed dialysis sessions and change in quality of life.
The trial was discontinued at a median follow-up of 1.1 years because researchers found no significant differences in outcomes between groups and there was no reduction in mortality or hospitalizations for the intervention vs. usual care.
Despite this insufficient evidence, researchers concluded that embedding a trial into clinical care delivery with no on-site research personnel still allowed for the efficient enrollment of a large study population and the ability to acquire data while safely monitoring patients.
“There is tremendous interest in pragmatic trials that leverage existing clinical infrastructures because of their potential to produce results that are highly generalizable to the non-research setting and reduce the time and resources required for trial conduct,” the researchers wrote. “Several important successes of the Time trial provide a foundation for future pragmatic trials in dialysis, as well as in other health care settings.” – by Melissa J. Webb
Disclosures: Dember reports compensation from the NKF, being a member of a data monitoring committee for Proteon Therapeutics and consulting for GlaxoSmithKline. Please see the study for all other authors’ relevant financial disclosures.